关键词: 总胆汁酸测定, 酶循环法, 试剂盒, 行业标准, 修订

Abstract:

Objective： To revise the industry standard YY/T 1204-2013 “Total bile acids assay kit （Enzyme cycle method）”.Methods： The performance indicators related to the product appearance， fill volume， reagent blank， linear range， accuracy， analytical sensitivity， precision， and stability in the industry standard YY/T 1204-2013 “Total bile acids assay kit （Enzyme cycle method）” have been revised， and validated using 17 total bile acids assay kits （enzyme cycle method）.Results： All the tested reagent kits met the appearance and loading capacity criteria. The blank absorbance values were ≤0.80 for all kits， and variation rates of blank absorbance were ≤0.04. The linear ranges of all the tested kits covered ［3， 150］ μmol·L^-1， with correlation coefficients ≥0.990 0 within this interval. Linear absolute deviations fell within ±3.0 μmol·L^-1 for all kits except one， while the absolute and relative deviations of the remaining kits all met the requirements. Accuracy verification showed satisfactory recovery rates for all kits， although three kits failed to meet acceptance criteria in method comparison experiments （slope or concordance rate）. All kits satisfied requirements for analytical sensitivity and precision （repeatability ≤5.0%， inter-assay CV ≤10.0%）. Stability testing of kits approaching expiration dates and those subjected to 37 ℃ conditions demonstrated compliance with specifications. The above results indicate that the indicator settings of the revised standard are rigorous and reasonable.Conclusion： This revision has made the product performance indicators of the standard updated and more practical， providing a scientific basis for the research and development， testing， and post-marketing supervision of the total bile acids assay kits.

Key words: Total bile acids assay, Enzyme cycle method, Kit, Industry standard, Revision